18 and older, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Sensitivity and Specificity of BIOZEK COVID-19 Antigen Rapid Test on a Sample Collected by Healthcare Professionals.Primary· 1 visit, up to 2 hours
The Biozek Antigen Rapid Tests performed by the trained study personnel on the samples collected by the trained study personnel. Sensitivity was calculated using (TP/TP+FN)\*100% formula.
Specificity was calculated using (TN/TN+FP)\*100% formula.
Sensitivity - Test performed by trained study personnel
Group
Value
95% CI
BIOZEK COVID-19 Antigen Rapid Test
100
Specifity - Test performed by trained study personnel
Group
Value
95% CI
BIOZEK COVID-19 Antigen Rapid Test
98
Sensitivity and Specificity of BIOZEK COVID-19 Antigen Rapid Test on Self - Collected Samples.Secondary· 1 visit, up to 2 hours
The Biozek Antigen Rapid Tests self-performed performed by the subject on the self - collected samples by the subjects. Sensitivity was calculated using (TP/TP+FN)\*100% formula.
Specificity was calculated using (TN/TN+FP)\*100% formula.
Sensitivity - Test performed by the subject
Group
Value
95% CI
BIOZEK COVID-19 Antigen Rapid Test
100
Specificity - Test performed by the subject
Group
Value
95% CI
BIOZEK COVID-19 Antigen Rapid Test
98
Sponsor's own description
This is a research study to evaluate the Sensitivity and Specificity of BIOZEK COVID-19 Antigen Rapid Test on samples collected by a healthcare professional versus self-collection; and to perform analysis to compare results. In addition, to obtain RT-PCR test results, performed prior to enrollment, and compare all three results.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
NCT03305341 — Proof-of-Concept Clinical Pharmacology Trial for COVID-19 Antigen Presentation Therapeutic Biologic Mix
· EARLY_PHASE1
· active not recruiting
NCT06482138 — Dysfunction of Olfaction After COVID-19 Infection: Morphological and Histomolecular Investigation
· NA
· recruiting
NCT04924803 — Community Developed Technology-Based Messaging to Increase COVID-19 Vaccine Uptake Among People Who Inject Drugs
· NA
· active not recruiting
NCT05013632 — COVID-19 International Drug Pregnancy Registry
· recruiting
NCT04806061 — Urine Alkalinisation in COVID-19
· NA
· active not recruiting
Other Mach-E B.V. trials
Trials by the same sponsor.
NCT04926779 — Study Utilizing BIOZEK COVID-19 Antigen Rapid Test
· NA
· completed
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Mach-E B.V.
Last refreshed: 29 June 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04805892.